Large Scale GMP API Manufacturing

With access to ten sites in India, supported by an R&D centre, technical team and project management team in Baroda, we are large scale non GMP/GMP intermediates and API manufacturers.

Our flagship site is Ratlam, housing 22 manufacturing blocks and over 415 reactors with sizes up to 15000 litres. To support our expert API manufacturers, our site boasts three dedicated and 15 multi-purpose blocks with powder processing and micronization facilities. Delivering batch sizes up to 1000kg, our 1225-strong API manufacturing team offer a wide range of reaction capabilities.

So when scaling up your project, we can offer dedicated scientists, rapid internal tech transfer from the UK and instant GMP API manufacturing capacity at Ratlam. You also have the security of knowing that as large scale API manufacturers we have additional plants and sites should your demand increase significantly. Furthermore, our API contract manufacturing capability is supported by our quality assurance (QA) team that maintain the highest level of quality standards across the site. In fact, 20% of our staff at the site are dedicated to quality.

Our parent company Ipca Labs has been manufacturing GMP APIs and supplying these commercial APIs to seven of the top big pharma companies for over 20 years. As dedicated API manufacturers, we meet very high standards of EHS and QA compliance. Our commercial GMP API manufacturing sites in India have been inspected and approved by regulatory bodies including FDA, MHRA, SA MCC, TGA, Japan PMDA to name a few.

If you’d like to know more about our large scale GMP API manufacturing capabilities or any of our contract research and manufacturing services, then please get in touch today.